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SARA - Substance Abuse Research Assistant

Developing a Flexible App Data Collection Tool for Substance Use Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03255317
Acronym
SARA
Enrollment
74
Registered
2017-08-21
Start date
2017-08-24
Completion date
2018-04-13
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use

Keywords

Substance use, youth, mobile health, data collection adherence, user engagement

Brief summary

The aim of this study is to evaluate the efficacy of engagement strategies for increasing daily data collection adherence among substance-using youth between the ages of 14 and 24. The primary hypotheses of this study are that: (1) receiving a reinforcer after completing daily data collection activities will predict next-day completion of targeted data collection activities; and (2) receiving a notification prior to 6pm (when data collection activities open) will predict same-day completion of data collection activities.

Detailed description

Substance use among adolescents and emerging adults remains an alarming public health issue which is associated with the leading causes of death. Although mobile applications are a promising data collection tool for understanding substance use among youth, existing mobile applications are limited in that they are not readily modifiable nor designed for long-term use. To address these challenges, our research team has developed a prototype mobile application named SARA (Substance Abuse Research Assistant) that contains multiple data collection tools (e.g., ecological momentary assessments, active tasks) and features various engagement strategies (reinforcers or notifications) designed to encourage data collection adherence over an extended period of time. Baseline reinforcers which are administered to all participants include: (1) a virtual aquarium that participants see after opening the app; (2) virtual fish to populate the aquarium, which participants can earn points to unlock by completing daily data collection activities; (3) a new aquarium interface (i.e., leveling up) that participants unlock after using the app for a predetermined amount of time; (4) small financial rewards for each 3-day streak of completing daily data collection activities; and (5) reminder text messages/phone calls from research staff following predetermined reminder schedules. Key reinforcers and notifications are described in detail in the intervention section. This study examines the impact of these key engagement strategies on participant compliance with daily data collection activities over a 30 day field testing period. The primary analyses will use a log linear generalization. The primary longitudinal binary outcome for the reinforcers will be whether on the following day the participant completes one or more self-report validated survey items. The secondary longitudinal binary outcome for the reinforcers will be whether on the following day the participant completes both active tasks. Survey questions answered prior to the randomization as well as the completion of one or more survey questions on the day prior to randomization, and the completion of both active tasks on the day prior to randomization, may be used as control variables in the above analyses of reinforcers. The primary longitudinal binary outcome for the notifications will be whether on the same day the participant completes one or more self-report survey questions. The secondary longitudinal binary outcome for the notifications will be whether on the same day the participant completes both active tasks. The completion of one or more survey questions on the day prior to, and the completion of both active tasks on the day prior to, the randomization will be included as control variables for the notifications.

Interventions

BEHAVIORALReinforcers

Memes/Gifs: Immediately after completing their daily ecological momentary assessment using the app, each participant is randomized to receive an inspirational or funny meme or gif that is displayed within the app. Life Insights: Immediately after completing both daily active tasks using the app, each participant is randomized to unlock a life insight. Life insights track data provided by the participant, are stored in a virtual library within the app, and are regularly updated with recent data points.

BEHAVIORALNotifications

Reminder Push Notifications: All participants receive a push notification reminder from the app at 6pm (the time at which data collection opens) to complete their daily data collection activities. Each day, each participant will be randomized to receive either a generic reminder or a reminder that contains more detailed information (e.g., about upcoming incentives). Inspirational Push Notifications: Each day, each participant will be randomized to receive a push notification at 4pm that contains inspirational song lyrics or celebrity quotes.

Sponsors

Harvard University
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

At each time point at which a participant is eligible to receive an engagement strategy, the participant is randomized to either receive the strategy or not receive the strategy. Participants are only eligible to potentially receive some engagement strategies after completing their self-report survey questions and/or active tasks that day (see intervention section for more information).

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

1. Between the ages of 14 and 24, 2. Has an Android or iPhone smartphone, 3. Self-reported past-month binge drinking (4 drinks for females/5 drinks for males on one occasion) and/or any past-month cannabis use in the absence of a medical marijuana card

Exclusion criteria

1. Unable to understand English, 2. Not medically stable at intake, 3. Unable to provide informed consent/assent (e.g., cognitively impaired, intoxicated) at intake, 4. Parental consent cannot be obtained at intake (for participants age 14-17), 5. Unable to download the SARA app on smartphone at intake

Design outcomes

Primary

MeasureTime frameDescription
Completion of daily self-report survey questionsSame day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.Completion of daily self-report survey questions will be measured as completed' or not completed. Survey questions include validated items that assess daily mood and substance use. Completed = 1 or more questions answered; not completed = 0 questions answered.

Secondary

MeasureTime frameDescription
Completion of daily active tasksSame day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.Completion of daily active tasks will be measured as completed' or not completed. Completed = 2 tasks; not completed = 1 or 0 tasks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026